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The Medcomp® T3 T catheter is a triple lumen catheter indicated for use in attaining short-term vascular access for hemodialysis, apheresis. The third internal lumen is intended for infusion, power injection of contrast media and central venous pressure monitoring.

The catheter is intended to be inserted in the jugular, femoral or subclavian vein as required. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media.

The T3 CT is a triple lumen catheter with a designated lumen for power injection, infusion or pressure monitoring. Each catheter lumen terminates through an extension to a female luer- lock connector. Each extension has an in-line clamp to control fluid flow and the clamp I.D. Ring is marked with the priming volume plus power injection rate is printed on the center clamp. The transition between lumen and extension is housed within a molded hub. The hub is marked with the catheter French size, lumen length and both the company and catheter design name. The outer extensions are clear and marked with "Do Not Power Inject" and the center extension is a translucent purple pigment printed with "Power Injectable". The catheter is available with either straight or curved out extensions.

The catheter lumen is composed of a soft, thermo-sensitive, polyurethane material with barium sulfate for radiopacity. At bodv temperature the catherer lumen becomes softer to reduce the risk of vessel trauma.

The catheter hub and extensions are molded from soft pliable polyurethane to increase patient comfort. The suture wing is flexible with suture holes for catheter securement.

The provided document does not contain a study demonstrating acceptance criteria or device performance in the way typically expected for a medical device efficacy or performance study. This document is a 510(k) summary for a hemodialysis catheter (T3 CT).

Instead of a clinical study or performance data against specific acceptance criteria, the submission relies on demonstrating substantial equivalence to existing legally marketed predicate devices. This means that instead of proving the device meets certain performance metrics through a new study, the applicant argues that the new device is as safe and effective as devices already on the market because it has the same intended use, materials, anatomical location, basic design, performance, labeling, manufacturing process, and method of sterilization.

Here's an analysis based on the information provided, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, there is no explicit table of acceptance criteria and reported device performance from a specific study presented in this 510(k) summary. The submission asserts that the device "meets the performance criteria of design verification as specified by ISO standards, guidance documents and test protocols." However, the details of these criteria or the test results are not included.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. No new clinical or performance test set (as in a study to evaluate efficacy or performance against specific metrics) is described. The submission relies on equivalence to predicate devices and adherence to design verification standards (ISO, guidance documents, test protocols), but details of these tests are not provided.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. No ground truth establishment for a test set is described as part of this 510(k) summary.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring an adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a medical device 510(k) summary for a catheter, not an AI software or imaging device that would typically undergo an MRMC study.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

Not applicable. This is a medical device 510(k) summary for a catheter, not an algorithm or AI system.

7. Type of Ground Truth Used

Not applicable in the context of a new efficacy/performance study. The "ground truth" for this 510(k) submission is effectively the established safety and effectiveness of the identified predicate devices, based on their prior clearance and market history.

8. Sample Size for the Training Set

Not applicable. This is a medical device 510(k) summary for a catheter. The concept of a "training set" is relevant for machine learning algorithms, which is not what this submission is about.

9. How the Ground Truth for the Training Set Was Established

Not applicable. See point 8.

Summary of the Acceptance Criteria and "Study":

The "acceptance criteria" for the Medcomp® T3 CT catheter, as presented in this 510(k) summary, are primarily based on:

• Substantial Equivalence: The device is considered substantially equivalent to legally marketed predicate devices (K033570, K083675, K102605 as primary, and several others as secondary). This is the core "study" or justification for its market clearance. The argument is that "there are no differences that raise new issues of safety and effectiveness."
• Design Verification: The submission states that the "proposed device meets the performance criteria of design verification as specified by ISO standards, guidance documents and test protocols." While the specific tests and their results are not detailed, this implies that the device underwent engineering and materials testing to ensure it meets established specifications for medical catheters (e.g., strength, flow rates, material compatibility, etc.).
• Biocompatibility: The materials used meet the requirements of ISO 10993, and all materials have been cleared under past approved 510(k)s. This demonstrates the materials are biologically safe.

Conclusion:

The Medcomp® T3 CT 510(k) submission (K123292) for a hemodialysis catheter does not describe a clinical study to prove device performance against specific efficacy or performance acceptance criteria. Instead, it relies on demonstrating substantial equivalence to existing predicate devices and adherence to established design verification standards and biocompatibility requirements. This is a common pathway for medical device clearance, especially for devices that are modifications or improvements upon existing technologies rather than entirely novel ones.

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